fda glp-1 compounding warning letters september 2025 Congress Introduces SAFE Drugs Act of 2025, Expanding Oversight of Compounded Drugs and Telehealth Providers FDA cracks down on 'misleading'

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The FDA also required changes to the labels to achieve a more uniform presentation of side effects and risk information for all of the drugs in the GLP-1 category, including adding or changing subsections for Acute Pancreatitis and Severe Gastrointestinal Adverse Reactions and revising the Patient Counseling section and Medication Guide. Some of the labels were also updated with post-marketing reports of hair loss (alopecia) and the neurological symptom of altered sense of touch, or dysethesia

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